With personal computers becoming ever more popular over the past years, electronic documents have gradually taken the place of handwritten documents. Electronic documents offer many advantages over paper documents, but they also involve disadvantages relating to issues such as electronic data security.
21 CFR Part 11 is a code of regulations designed by the FDA to promote the use of electronic data and electronic signatures for documenting, inter alia, pharmaceutical products. 21 CFR Part 11 provides guidelines for the use of electronic tools in connection with the manufacture of products approved by the FDA.
The 21 CFR Part 11 regulations came into force in August 1997, but do not grant exemption for systems put into use before that date. Therefore, all systems subject to FDA control must comply with 21 CFR Part 11.
The general idea of 21 CFR Part 11 is that companies should at all times be able to document who did what and when. An indispensable requirement is that all data modifications must be traceable, whether intended modifications, wrong corrections or outright falsifications. This version management of all electronic data is referred to as an “audit trail” according to the terminology used in 21 CFR Part 11.
The audit trail requirement for electronic data is relatively new for pharmaceutical products, but the concept is established in the financial sector and in accounts departments globally, which have had to comply with similar requirements for decades.
It is well known that computers are typically composed of a plurality of operative units, such as floppy disk drives, hard disks, modems, network connections and graphical accelerator cards. It is of interest in this connection to be able to cause the computer to operate in several different states where operative units are connected and disconnected in dependence on the selected state. It is eg desirable that access to an operative unit is allowed in a first state, while this access is not allowed in a second state. This may inter alia be desirable in order to secure personal data on the hard disk of a computer, which is used by several users. This security can eg comprise security against unintentional destruction of personal data as well as security against spreading of virus between operative units in the computer.
It is therefore of interest to provide a control device for computers with one or more operative units where the computer can operate in at least two states, and where the control device is adapted to connect and disconnect the operative units in dependence on the state in which the computer is to operate.
In research work such as in the medical research industry developing and manufacturing medical devices and drugs it is of utmost importance that all research work can be precisely documented. In case of amendments (eg by additions, changes or deletions) being made to existing files that it can be established beyond any doubt who made the amendment and when. Such documentation is of great value, if not a requirement, for having a newly developed device or drug approved by national or supranational authorities such as the United States Food and Drug Administration (FDA). Each production batch of medical drugs must be documented in detail. Each human intervention in the production process potentially involves the risk of errors being made, which can have serious consequences. It is therefore essential to have a complete and reliable record, at each step in the production process, of both human intervention and automatic steps carried out. This allows possible errors or minor deviations to be tracked.